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follitropinJanuary 11 2016

Teva has launched a recombinant human follicle-stimulating hormone in the UK. Ovaleap (follitropin alfa, r-hFSH) is a fertility treatment for anovulation, stimulation of follicular development and spermatogenesis and is a biosimilar to Gonal-f from Merck Serono.

 

In the UK, Ovaleap is licensed for the treatment of anovulation and the stimulation of follicular development in women in conjunction with assisted reproductive technologies (ART) or with a luteinising hormone. It is also indicated for the stimulation of spermatogenesis in men.

It can be self-administered via a re-useable self-injection pen which can hold three different cartridge sizes (300 IU, 450 IU and 900 IU). Features of the pen include:

  • a large dosing window with legible numbers confirming the dose size, while a clear cartridge holder lets the patient see how much medication is inside;
  • a dial-back feature allowing quick and easy correction if the dose is set incorrectly;
  • the injection is administered simply by pressing a side-button.

Christophe Pelletier, Vice President Women’s Health Europe, Teva Pharmaceuticals, said: “As a leading global pharmaceutical company that delivers patient-centric healthcare solutions to millions of people every day, we hope that by providing a r-hFSH alternative, more people facing infertility will be able to access and benefit from treatment.”

Teva says that Ovaleap “demonstrated therapeutic equivalence with Gonal-f in clinical trials, including a Phase III study in infertile women undergoing IVF, showing no difference between the two treatments in the number or quality of eggs (oocytes) retrieved from the ovaries, or in the number of babies born. Ovaleap is also proven to have a comparable safety profile to its reference product.”

As the prescription only (POM) product is new to the market, it is included in the Yellow Card black triangle ▼ monitoring scheme.

Links:

Teva announcement

Yellow Card Scheme

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